The invention relates to a method and system for filling a multi-compartment container, each compartment holding a separate component, to be mixed with one another by the end-user prior to use.
A variety of formulations for human use are stored in the form of a dry particulate matter (powder) and are mixed with a liquid shortly before use to form a true solution or a dispersion. This is the case, for example, with various nutritive formulas, including maternal milk substitute formulas (baby formula), adult feeding formulas such as dietetic powders and a variety of drugs, e.g., antibiotics. The shelf life of such mixed liquid formulations is limited, and this dictates the need to prepare them only shortly before use. The limited shelf life of the mixed formulation is the result of a loss of activity of an active ingredient in the formula, for example, loss of activity due to accelerated oxidation and/or hydrolysis once the ingredient is mixed with a liquid, etc. In addition, in many cases, the mixed formulation can be more susceptible to micro-organism contamination.
In some applications, for example, formula for newborn babies and various drugs including antibiotics, it is important that a correct amount (weight and/or volume) of the dry particulate material be admixed with a correct amount (weight and/or volume) of the liquid when preparing the resulting formula. Too much or too little of any one of the required components alters the ratio and changes the resulting formulation which may need to be within close tolerances to have the appropriate effect. For example, in the case of baby formula if there is not enough dry formula the mixed liquid formulation will be diluted in which case the baby or infant will be undernourished, or if there is too much dry formula the mixed liquid formulation will be too concentrated which may give rise to digestive problems and vomiting.
In addition, in some applications it may be necessary that the filling, storing and mixing of the two compartments be performed under hygienic and in some cases sterile conditions and that the two components be of appropriate sterility and quality.
The preparation of baby formula in the home and hospitals is typically accomplished by providing cleaned and sterilized bottles and nipples, measuring a quantity of the powdered (dry particulate) material from a canister and placing it in the previously cleaned and sterilized bottle to which an appropriate measured amount of water (generally tap water), saline solution or milk is added. The nipple is then attached and the two components or components are then agitated to form the mixed liquid formula. A variety of drugs, for example, antibiotics are prepared in a similar manner by the pharmacist or the end-user.
In applications where a formula prepared by mixing two components has a short shelf-life or where the quantities, quality or sterility of the components is an important consideration in the preparation of the formula, a single container which could separately store the two components until the mixed formula is to be dispensed, permit the two components to be mixed in the container and permit the mixed formula to be dispensed from the container would be useful. In some such applications it may further be desirable that the container be pre-packaged and yet further desirable that it be configured and adapted for a single use by the end-user and even more desirable that the container be unusable after the single use. Such storage and dispensing containers would offer convenience, safety and potential savings to the end-user.
First, a pre-packaged two-compartment storage and dispensing container offers the convenience of having both component parts of a mixed formulation supplied in the correct amounts in a single easy to use container that is always ready to be mixed. In this manner, a traveler may take along as many pre-packaged containers as desired and mix the formula for use at any time, without having to measure the two or more components, or worry about forgetting or obtaining one of the components of the formula while traveling. Such a pre-packaged container, filled and packaged under the appropriate conditions, separately storing the component elements of a formula in a ready to mix manner, and adaptable to mix and dispense the resulting formulation provides a complete system for the end-user.
Second, two-compartment storage and dispensing containers offer the safety of being packaged in a manufacturing plant where the sterility of the environment and the quality and sterility of each of the components and mixed formula can be controlled. In addition, the quantity of each of the two separate components can be controlled through precise measurement if prepackaged in a container in a manufacturing facility.
A multi-compartment container of the type that meets the need described above are described in U.S. Pat. No. 6,045,254 whose disclosure is incorporated by reference herein. A method and apparatus for filling multi-compartment containers, and more specifically to an automated method and apparatus for filling multi-compartment, and preferably two-compartment containers which separately store two or more components for later mixing and dispensing is described herein.
In one embodiment, the automated method and apparatus is adapted for filling a two-compartment container having two open ends, where two or more components intended to be mixed prior to use are stored separately in each compartment. The first of such components is typically a liquid and the other a particulate solid, e.g., powdered substance. Of course, two liquids or two particulate solids (e.g. powders) may be separately stored for later mixing.
The method and apparatus for preparing a multi-compartment container may further check for leaks, maintain a sterile environment and prevent contamination of the respective compartments, including contamination from the components of the other compartments.
An example of the two-compartment container or a precursor to the two-compartment container that may be filled by the process and method described herein includes a housing having openings at both ends, the housing having a partition wall between the two openings which defines a first cavity and a second cavity. The partition wall preferably forms a seal with the housing and more preferably is movable between a sealed position, whereby a seal is formed between the first and the second cavities (xe2x80x9cinter-compartmental sealxe2x80x9d), and an unsealed position, whereby the first and second cavities intercommunicate.
When the partition wall is in the sealing position the contents of the two cavities, whether liquid or solid, do not mix. The container may further be provided with a displaceable member to move the partition wall from its sealed position to its unsealed position. In addition, or alternatively, the displaceable member may move the partition wall to its sealed position.
The seal of the partition wall may include an O-ring seal. The container may further comprise sealing members, sealing membranes, or sealing assemblies for sealing the openings so that compartments may be formed. A secondary seal for sealing the openings may also be included. According to a further feature of this embodiment there may also be provided a feeding nipple attached to the displaceable member or the container and in communication with the opening. The secondary seal may be exterior to the feeding nipple.
Another example of a two-compartment container comprises side walls, an opening at a top end, an opening at the bottom end capable of being fitted with a bottom wall, and a partition wall dividing the container in a fluid-tight manner into two compartments, each for holding one of the two components. The container may include a displaceable vertical elongated member with a bottom end connected to the bottom wall and its top end connected to the partition wall such that vertical axial displacement of the bottom wall yields a vertical displacement of the displaceable elongated member causing movement of the partition wall.
The partition wall may also be integrally connected to an internal face of the side walls through a connecting zone which is breakable or tearable by vertical displacement thereof, and the elongated member extends downwardly from the partition wall to the bottom wall of the container. In accordance with this embodiment, displacement of the elongated member causes vertical displacement of the partition wall which yields a break or tear in the connecting zone. The tearing or breaking away of the partition wall results in flow communication between the two compartments and allows mixing of the contents of the two compartments. Mixing of the contents of the two compartments yields a formulation in a ready-to-use form which may then be dispensed.
In order to provide access to the lower compartment during the container filling process, the bottom wall may be provided as a separate piece from the container housing and fitted into the opening at the bottom of the container. After the lower compartment is filled with a component for a formulation, the bottom wall piece may be sealed to the container housing. The bottom wall may be flexible to allow vertical displacement at its center. Alternatively, rather than being entirely flexible, the bottom wall may also be rigid, having a flexible peripheral portion, allowing vertical displacement. In accordance with one embodiment, the bottom wall, when at rest, is downwardly arcuated and by applying upward pressure it assumes an alternate position where it is upwardly arcuate and pushes the elongated member and causing vertical displacement of the partition wall. In accordance with another embodiment, the bottom wall, when at rest, is upwardly arcuate and it is displaced by pulling it downward into the alternate position where it is downwardly arcuate. Such pulling may be by means of a handle or knob fixed at the bottom wall. As can readily be appreciated, a container as in these embodiments can be manipulated by one hand.
The displaceable member may be provided with a safety mechanism for avoiding unintentional axial displacement. By one example, the safety mechanism includes at least one radially projecting lug which is engaged in a partial circumferential groove in the container, and the displaceable member is rotated between the first angular position where the at least one lug is engaged in the groove and a second angular position wherein the lug is disengaged permitting axial displacement.
The container may comprise an integral closure member sealing the top opening, e.g., a breakable seal, which once broken allows one to dispense the mixed formulation from the container. The breakable seal may comprise a membrane where the membrane may be a foil or a non-metallic membrane, such as a plastic or a polymer membrane, and may have a single-layer structure or a multi-layered laminate structure. In this embodiment where the membrane seals the dispensing opening, the membrane seal is preferably of the type that may be peeled off to attach an appropriate dispensing system.
In another embodiment of the container, the partition wall may project from a manipulable portion of a displaceable member, which is fitted within an opening of the container and is user operable to allow displacement control of the partition wall. The manipulable portion may be exterior to the housing and preferably is easily accessible and operated by the end-user. In one example, the partition wall is connected at an end of one or more stems projecting from the manipulable portion.
In the case of a single stem, the stem will typically be centrally located, and in the case of a plurality of stems, they will typically be disposed in the periphery of the partition wall. In another example, the partition wall and the manipulable portion may be connected by a peripheral wall formed with openings. In a further example, the connection between the partition wall and the manipulable portion is by means of radial wall sections. The manipulable portion of the displaceable member may, in accordance with one embodiment of the invention, be adapted for screw engagement with the housing such that axial displacement is achieved as a result of helical displacement during rotation. In this case, the seal formed by the partition wall is controlled by rotation of a threaded displaceable member. In accordance with another embodiment of the invention, the displaceable member is engaged with the housing such that it is axially displaceable by means of pulling, or pushing, on the manipulable portion such that the partition wall engages or disengages with the neck portion.
The container may also be provided with a closure assembly fitted at an opening. A membrane as described above may comprise the closure assembly. The closure assembly may further be replaceable and may or may not cooperate with the displaceable member. The closure assembly may comprise a removable stopper.
The displaceable member may have a peripheral portion for displaceable engagement with a top end of the housing, and may have an outwardly extending aperture defining the dispensing opening. In another variation of a two-compartment container, the displaceable member may be engaged in a displaceable manner to the bottom end of the housing. Typically, in accordance with this embodiment, the displaceable member has a wall, defining the bottom wall of the container, which is provided with a sealable opening to allow filling of a component into a first compartment. Alternatively, the end of the displaceable member corresponding to the bottom end of the container may be completely open to allow filling of the first compartment. In other words, the bottom end of the displaceable member may not have a wall-like structure. This opening may be sealed with a stopper-like structure or sealed with a membrane structure using a heat seal process. This embodiment typically has a top opening opposite the bottom opening which is fitted with the displaceable member. The top opening may be a dispensing opening, but is not necessarily different than the sealable opening in the displaceable member.
The dispensing opening may be fitted with a simple membrane, such as, for example, a foil or laminate, or a closure assembly fashioned in a manner to allow a controlled release of the formulation from the container. The closure assembly fashioned in a manner depending on the intended use. For example, in the case of a container for medicinal formulation, the closure assembly may for example be a pierceable rubber stopper, adapted for inserting a syringe needle for withdrawal of the medicinal formulation; the closure assembly may also be fashioned in a manner allowing dispensing of a fixed amount of the formulation each time for a plurality of occurrences; the closure assembly may also be fashioned in the form of a spoon-shaped dispensing unit; in the case of a container intended for use as a baby""s feeding bottle, the closure assembly may be a nipple sized and shaped according to its intended application. The closure assembly may also be fitted with an additional cover, e.g. foil covering a stopper or a cap covering the nipple, to secure the closure and/or maintain sterility. In the case of a cap covering a nipple, the cap may be fitted in a manner to seal the nipple""s opening so as to avoid spillage of the liquid component during storage prior to mixing the liquid formulation.
Either both or one of the top opening and the bottom opening of the container may be sealed with a membrane. The membrane may be a foil or a non-metallic membrane, such as a plastic or a polymer membrane, and may have a single-layer structure or a multi-layered laminate structure. And as discussed before, where a membrane seals the dispensing opening, the membrane seal is of the type that may be peeled off to attach an appropriate dispensing system. For example, in a baby feeding bottle application, a baby feeding rubber nipple may be attached to the dispensing opening.
The multi-compartment container may be fashioned for a variety of uses. The container may serve as a baby""s feeding bottle, in which case the first compartment may contain a liquid, typically sterilized water, and the second compartment may contain a powdered baby""s formula. In another application, the container may be fashioned for storage of two components of a medicinal formulation, for example, the first compartment may contain a liquid, e.g., water or a sterilized saline solution, and the second compartment may contain a dry particulate drug formulation to be mixed with the liquid prior to use, e.g. an antibiotic drug formulation. Depending on the type of the formulation, the two components may be both liquids, one may be a liquid and the other may be a dry formulation or both may be dry formulations.
The relative size of the first compartment and the second compartment can be designed according to their intended use. The container may be made for a single use, the container generally being disposable after its single use. In addition, the container may be made to be recyclable, i.e. to be returned to the manufacturer after use for refilling. Furthermore, the container may also be made in a manner to allow refilling with the two components by the end-user. The container may further be constructed and made of materials to withstand heating the container in order to warm its contents.
It may be advantageous in some applications to provide a container which is only capable of a single use, in particular a pre-packaged container which is only capable of a single use, in order to prevent an end-user from reusing the container. Such a container may provide a manufacturer with control over the quality of the product delivered by preventing the end-user from refilling and reusing the container. A pre-packaged container offers the advantages of control over the proportion, quality and sterility of the components used and the delivered mixed formulation. It is envisioned that a single use container can be accomplished by controlling the strength of materials and construction of the container, preventing the ability to refill, destroying the operability of the container or a combination of these. For example, the container may be designed of a thin plastic material, or with a closure system which cannot be removed or re-closed after opening, or a seal that is not capable of being reformable (resealed) after it has been broken.
In accordance with one embodiment of the invention, a process and apparatus for filling a multi-compartment container for holding at least two separate components may comprise: providing a housing of a container having an internal space between a top opening and a bottom opening and a partition wall positioned between the top opening and the bottom opening defining an upper compartment and a lower compartment; conveying the container into a first component filling station; introducing a predetermined amount of the first component into the lower compartment through the bottom opening; sealing the lower compartment; conveying the container into a separating and rotating station; rotating the container so that the top opening is in an upward position; conveying the container into a second compartment filling station; filling the upper compartment with a predetermined amount of the second component of the formulation through the top opening; and sealing the upper compartment by sealing the top opening.
The process may further include one or more of the following steps; testing the integrity of the inter-compartmental seal, and filling one or more of the compartments under positive air pressure relative to the ambient environment to reduce contamination.
In another embodiment, the process comprises:
(a) providing a housing having a top and a bottom opening and a partition wall between the openings for forming a seal between a bottom and a top cavity;
(b) introducing a first component into the housing through one of the openings;
(c) introducing the second compartment into the housing through the other opening; and
(d) sealing the openings.
By another embodiment, the process comprises: providing a housing for a container having an internal space extending between two open ends; positioning a displaceable member into the housing, the displaceable member having a partition wall for fluid-tight sealing engagement with the container housing between the two open ends, and being at least axially displaceable between a first position where the partition wall forms a fluid-tight seal with the container housing, and a second position where the partition wall disengages from the container housing to allow flow communication between the two compartments; positioning the displaceable member into the first position in the container; introducing a first component of the formulation into the first compartment through one of the two open ends and sealing that open end; and introducing the second component into the second compartment through the other open end; and sealing that other opening.
The process may further include one or more of the following steps; testing the integrity of the fluid-tight seal at the neck portion, rotating the container to change the direction of the open ends and filling one or more of the compartments under positive pressure to reduce contamination.
By another embodiment the process comprises:
(a) providing a body for use as a container having an internal space extending between two open ends, one of the two open ends being fitted with a displaceable member comprising, a wall portion sealably engaged with the body at that open end, a sealable filling aperture in the wall portion, a partition wall adapted to form a seal with the body and an extension member extending between the wall portion and the partition wall; the displaceable member fitted within the body such that the partition wall forms a seal creating a first compartment and a second compartment;
(b) introducing a first component through the filling aperture;
(c) sealing the filling aperture;
(d) introducing a second component into the opening opposite the displaceable member, and
(e) sealing the open end opposite the displaceable member.
The process may further include one or more of the following steps; testing the seal at the partition wall, rotating the container to change direction of the open ends and filling one or more of the compartments under positive pressure to reduce contamination. The process further may be performed under aseptic or sterile conditions.
The invention will now be illustrated in some specific embodiments directed toward a baby""s feeding bottle and a medicine container in accordance with the invention. It will be appreciated by the artisan that the same principle is also applicable in other applications and areas where it is desired to fill, preferably automatically, a multi-compartment container having two open ends for storing two or more components of a formulation which are to be mixed prior to use.